Senior Scientist Process Development

Secretome Therapeutics is a clinical-stage biotechnology company based in Plano, Texas, developing novel therapies derived from neonatal cardiac progenitor cells (nCPC). The Company's lead product candidate, STM-01, is a cellular therapy designed to modulate inflammatory and fibrotic pathways and support myocardial function in Duchenne Muscular Dystrophy (DMD) and Heart Failure with Preserved Ejection Fraction (HFpEF). Secretome is also advancing STM-21, a secretome-based therapeutic currently in preclinical development, and other novel nCPC-based products. About The Role Secretome is seeking a highly motivated Senior Scientist, Process Development, reporting directly to the Head of Process Sciences, to lead process development and optimization in support of our novel allogeneic cell therapies. This role will be responsible for the design, optimization and scale -up of cell processing workflows, the execution of cell processing runs and ensuring high yield, quality and regulatory compliance of the drug product. This role will work closely with Analytical Development, other cross-functional teams and external entities to establish fit-for-purpose processes, generate high-quality data and support process understanding, product characterization and technical transfer of processes into a GMP environment. What You'll Do Support optimization of cell therapy workflows from cell expansion to harvest and formulationExecution of small to medium scale cell processing in 3D BioreactorResolve challenges and explore alternative equipment or production unitsCoordinate with the Analytics team the in-process sampling and characterization of cell products and other relevant product attributesTroubleshoot existing processes and experimental challenges, identify root causes, and implement scientifically sound solutions, propose improvements through clear communication to senior managementDevelop protocols, reports, technical summaries, and other scientific documentation in accordance with company procedures and applicable regulatory expectationsMaintain accurate and complete laboratory records and ensure work is performed in accordance with safety and compliance requirementsPresent results, scientific conclusions and process improvements to cross-functional project teamsSupport laboratory operations, ensure material and equipment readinessWork strategically to accelerate the development and implementation of novel technologies for integration into new and existing drug productsDevelop platforms to support current and new product formats, increased product control, lower cost, and lower operational laboratory complexityParticipate in project team meetings and decisions, working closely with other functions such as Research, Analytical, Manufacturing, Program Management, and othersPrepare and present to collaborators and external entities (CDMO), on plans and roadmap to meet GMP manufacturing goalsSupport technology transfer of processes, and serve as SME with external organizationsSupport CMC (Chemistry, Manufacturing, and Controls) sections for regulatory filings (IND/BLA) Qualifications Ph. D/ Master degree in Biochemistry, Cell Biology, Bioengineering, Biological Sciences with min. 4/ 6 years of relevant industry experience in process development for cell therapiesStrong hands-on experience with stirred tank bioreactors at various scalesInnovative, problem-solving and organizational skills are requiredIn-depth knowledge of biotherapeutics processes with preferred experience using small and medium scale stirred tank bioreactors for cell therapiesDemonstrated ability to design and execute cell process development, assist in process gap analysis and provide scientific guidance and recommendations on process optimizationHands-on experience in upstream/downstream bioprocessingFamiliar with the FDA regulatory requirements for drug products and IND filingKnowledgeable of cGMP requirements for processes and technology transferAbility to technically troubleshoot and resolve challenges to successfully produce cell therapy products at a high-performance rateMust have strong interpersonal and communication skills, be a team player and be willing to work in a cross-functional environmentSupport generation of batch records and technical transfer packages